Application 075794

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	TABLET;ORAL	250MG;250MG;65MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL			2001-11-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreen Company	36503181-0fda-4127-b3f0-bdb1b56bb0ed	2026-08-24	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Rite Aid Corporation	80e58390-69fb-48f7-ad3a-a13f125cd921	2026-05-27	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
good sense migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	f052512b-e55a-4369-8c9c-453c9a5686a3	2026-05-13	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	HyVee Inc	76e21832-5c4c-4c73-9f87-1060abbd3d82	2026-05-08	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
Up and Up Migraine Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Target Corporation	acaffae6-2964-4529-b61a-19ddfc5fd669	2026-04-29	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
Care One migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	American Sales Company	be6c9dc5-853e-4342-ba6a-e5b7be5afe72	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
MIGRAINE FORMULA	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Meijer, Inc.	529b6ee6-043c-430a-b2e1-b63c81f10291	2026-04-08	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
good sense migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Sportpharm LLC	2a27da49-23d6-4035-8088-806ee22b98b0	2026-03-06	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	CVS Pharmacy	e130831a-ec50-467a-9e5c-ba6ebc7bef3c	2026-02-26	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
Leader Migraine Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Cardinal Health 110, LLC. dba Leader	b74a8baa-c7a2-4eed-8202-888d8ba829b9	2026-01-20	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794 ndc (product): 70000-0247
good sense migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	93e7ba56-5682-4184-9a93-3b4b972b0e72	2025-11-10	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	H E B	f2f9b930-7b54-46c5-8631-d673a52a9eb4	2025-09-19	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreen Company	5dcc2b01-6556-46bc-a451-f09dd0bd1eed	2025-09-04	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
Topcare Migraine Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Topco Associates LLC	a2a9fbec-639f-4002-aa34-51b4563fc38e	2025-09-04	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
Equaline migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	United Natural Foods, Inc. dba UNFI	28ab87e5-6b7d-4737-95e8-4f842ecd9408	2025-08-28	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
good neighbor pharmacy migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Amerisource Bergen	201f101a-3b53-4349-896c-6b86cdd9b831	2025-08-26	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Meijer Distribution Inc	8f1ee554-1021-4613-ba0e-aa02f8a751f8	2025-06-16	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
foster and thrive migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strategic Sourcing Services LLC	fe9bf032-fc8b-4b2d-8c6b-acdbe1f320bf	2025-06-11	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
Signature Care Migraine Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Safeway	66695667-97a3-4329-8ce0-0fffa8628951	2024-03-27	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
good sense migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Proficient Rx LP	ed491286-f756-42f7-9a35-ea0380d1ff58	2023-08-01	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70000-0247	Leader Migraine Relief	Acetaminophen, Aspirin, Caffeine	Cardinal Health	ANDA	Current
70000-0611	leader migraine relief	acetaminophen, aspirin, caffeine	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70518-0321	Leader migraine formula	Acetaminophen, Aspirin, Caffeine	REMEDYREPACK INC.	ANDA	Current
70677-0119	sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
70677-0119	sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
71713-101	Cove Migraine Relief	Acetaminophen, Aspirin, Caffeine	THIRTY MADISON INC	ANDA	Current
71713-101	Cove Migraine Relief	Acetaminophen, Aspirin, Caffeine	THIRTY MADISON INC	ANDA	Current
72288-295	basic care migraine relief	acetaminophen, aspirin, caffeine	Amazon.com Services LLC	ANDA	Current
72288-374	basic care migraine relief	Acetaminophen, Aspirin, Caffeine	Amazon.com Services LLC	ANDA	Current
81522-374	caring mill migraine relief	Acetaminophen, Aspirin, Caffeine	FSA Store Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8792	ORIG	2003-04-15